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On October 6, Merck and Ridgeback Biotherapeutics released two real-world clinical evidence and a non-clinical research advance
, the oral antiviral COVID-19 drug LAGEVRIO ™ (molnupiravir).
Among them, a preliminary analysis of data from the open, prospective real-world PANORAMIC study funded by the University of Oxford showed that in the UK, there was no evidence that the addition of AGEVRIO to routine care versus routine care alone reduced hospital stays and deaths on day 28 (not reaching the primary endpoint) in this UK-based targeting <most vaccinated adults aged 65; The overall incidence of hospitalization and mortality at day 28 was very low (0.
8% in both groups).
The PANORAMIC study was a UK clinical trial sponsored by the University of Oxford that included 25,783 participants who were randomly assigned to open-label therapy with LAGEVRIO plus regular care (n=12821) or routine care alone (n=12962); The average age of the participants was 56.
6 years, and 25,000 (97%) of the participants had data obtained for the main results
.
Almost all (>98%) of participants were vaccinated, and approximately 95% of participants received three or more doses of the SARS-CoV-2 vaccine
.
In the preliminary analysis, the primary endpoint of reduction in hospitalizations and deaths in the 28 days after randomization compared with usual care was not met
.
However, at the secondary endpoint (first self-reported recovery), a 6-day reduction in the median time was observed in the LAGEVRIO group, and after adjusting for age and baseline comorbidities, the first recovery time was estimated to be significantly improved by 4 days (10.
4 vs 14.
5 days)
in the LAGEVRIO group compared with the usual care group.
Analysis of real-world data from another observational retrospective study conducted by Israeli researchers, known as the Clalit study, showed that in a group of high-risk patients who were not hospitalized, LEGELIO reduced hospitalization and mortality in patients aged 65 years and older infected with COVID-19; But no evidence
of benefit was found in people aged 40-64 years.
Data from both studies have been published
online in preprint.
In addition, Merck also reported the results of a study on carcinogenicity in genetically modified mice, which showed that LAGEVRIO does not cause cancer
at any test dose.
